About this trial
In this study, patients who have undergone or will undergo a transcatheter edge-to-edge repair (TEER) for tricuspid valve regurgitation (TR) will be followed up for 5 years. The goal of this prospective and retrospective, observational, non-randomized, multicenter registry is to confirm that TEER is a feasible, safe and effective treatment option for TR and to evaluate the long-term efficacy and safety of TEER.
The main endpoints are:
* Change in tricuspid regurgitation grade: number of patients with a reduction in tricuspid regurgitation score by at least one grade * Composite of major adverse event: number of patients with composite of major adverse event (cardiovascular mortality, acute kidney injury, myocardial infarction, stroke or TIA, coronary revascularization, new onset AF or ventricular arrhythmia)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
At least 18 years old
Eligible for TEER procedure
Informed consent signed
Disqualifiers
Unwilling to provide informed consent
Trial population
Patients with tricuspid valve regurgitation eligible for transcatheter edge-to-edge repair
Trial design
Cohort
Prospective
Treatments tested in this trial
Transcatheter edge-to-edge repair (TEER)
Procedure/SurgeryMinimally invasive transcatheter-based edge-to-edge repair technique for tricuspid regurgitation
Treatment groups
Trial outcomes
Primary outcomes
Number of patients with a reduction in tricuspid regurgitation score by at least one grade
Number of patients with a reduction in tricuspid regurgitation score by at least one grade 30 days post-procedure
Composite of major adverse event
Number of patients with composite of major adverse event (cardiovascular mortality, acute kidney injury, myocardial infarction, stroke or TIA, coronary revascularization, new onset AF or ventricular arrhythmia)
Secondary outcomes
Number of patients with a reduction in tricuspid regurgitation score by at least one grade at 6 months post-procedure
Number of patients with a reduction in tricuspid regurgitation score by at least one grade 6 months post-procedure
Number of patients with a reduction in tricuspid regurgitation score by at least one grade 1 year post-procedure
Number of patients with a reduction in tricuspid regurgitation score by at least one grade 1 year post-procedure
Number of patients with a reduction in tricuspid regurgitation score by at least one grade 2 years post-procedure
Number of patients with a reduction in tricuspid regurgitation score by at least one grade 2 years post-procedure
Number of patients with a reduction in tricuspid regurgitation score by at least one grade 3 years post-procedure
Number of patients with a reduction in tricuspid regurgitation score by at least one grade 3 years post-procedure
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: